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Study diagram. *, each cohort will be screened up to 21 days prior to dosing; therefore, it is possible that screening for the next cohort will begin when the current cohort is being dosed. **, if severe AEs are noted during the first two cohorts, the SEC may stop the study. If severe AEs are noted during the final two cohorts, the SEC may proceed to the next cohort with a reduced dose level.
